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A Rapid Sterility Method Using Solid Phase Cytometry for Cell-Based Preparations and Culture Media and Buffers.

Mahsa Mohammadi¹, Aline Bauer², David Roesti³

¹AS&T/QC support, NTO, Cell & Gene Therapies, Novartis Pharma Stein AG, Schaffhauserstrasse, CH-4332 Stein, Switzerland.

PDA Journal of Pharmaceutical Science and Technology

|August 14, 2023

Summary

A new rapid sterility test (RST) using solid-phase cytometry was validated for cell-based therapies and media. This advanced method offers faster detection than traditional compendial sterility tests, ensuring product safety.

Keywords:

Cell-based preparations In-process control Rapid sterility test ScanRDI Time to detection

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Area of Science:

Biotechnology
Microbiology
Pharmaceutical Science

Background:

Traditional compendial sterility testing (CST) is time-consuming.
Cell-based therapies and their associated media require robust sterility assurance.
Rapid detection methods are crucial for efficient biopharmaceutical manufacturing.

Purpose of the Study:

To demonstrate and validate a rapid sterility test (RST) for non-filterable cell-based preparations.
To evaluate the RST for in-process control of media and buffers.
To establish the suitability of solid-phase cytometry for sterility testing.

Main Methods:

Utilized the ScanRDI® system based on solid-phase cytometry for microorganism detection.
Validated the RST for a CAR-T cell-therapy product with a 4-day time to detection (TTD).
Assessed the RST for in-process control of media/buffers using real-time detection with representative microorganisms.

Main Results:

The RST demonstrated high sensitivity, detecting down to one microbial cell.
Validation parameters including limit of detection, specificity, robustness, and repeatability were met.
Statistical evaluation confirmed equivalence between the RST and CST methods, with no significant differences detected.

Conclusions:

Solid-phase cytometry technology, via the ScanRDI® system, is a validated and effective alternative for sterility testing of cell-based preparations.
The RST is suitable for in-process control of media and buffers, offering significant time savings.
This rapid method meets regulatory standards (USP <1223>, Ph. Eur. 5.1.6, PDA TR No. 33).